FDA 510(k) Application Details - K092211

Device Classification Name	More FDA Info for this Device
510(K) Number	K092211
Device Name	CHESAPEAKE SPINAL SYSTEM
Applicant	K2M, INC. 751 MILLER DR.,SE LEESBURG, VA 20175 US Other 510(k) Applications for this Company
Contact	RICHARD WOODS Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OVD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/22/2009
Decision Date	03/05/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review